Li Neng
Intertek Testing Services Shanghai Ltd.,China
Abstract The update of Chinese cosmetics regulations in 2020 was introduced in detail.Sorted out and analyzed the requirements of the “Regulations on Cosmetics Supervision and Administration” and supporting documents,which can help cosmetics companies to deeply analyze the changes in cosmetics supervision policies,further understand the regulatory requirements,and respond to the latest changes in cosmetic regulations more smoothly.
Key words cosmetics;regulatory status;review
Since the “Regulations on Cosmetic Hygiene Supervision”was promulgated in 1989,the cosmetics industry in China has developed rapidly,and the number of cosmetics companies has increased from dozens to thousands.But at the same time of rapid development,there are also a series of problems,such as low quality and efficiency of industry development,insufficient innovation ability,low brand recognition,and illegal additions.In this context,the regulatory authorities issued the “Regulation on Cosmetics Supervision and Administration”[1](hereinafter referred to as the “New Regulation”)and adjusted a series of regulatory policies for cosmetics,such as the management of new cosmetic raw materials according to risk levels;changes in cosmetic classification ;qualification requirements for personnel engaged in cosmetic safety assessment.
The new regulation has been implemented on January 1,2021,and the “Regulations on Cosmetic Hygiene Supervision” was repealed at the same time.The new regulation has six chapters and 80 articles,implement the reform requirements of “delegation,regulation and service”,improve the classification management system of cosmetics and cosmetic raw materials,simplify the registration andnotification procedures,encourage and support cosmetic research and innovation,and optimize the corporate innovation system environment.Safety assessment and efficacy assessment become “mandatory need”.At the same time,the corresponding supporting documents of the new regulation have also been issued for soliciting opinions.Therefore,in order to help cosmetics companies to timely understand and grasp the domestic cosmetics regulatory trends under the new regulations,and adjust themselves to meet the new requirements as soon as possible according to the new changes,the author collects and summarizes the regulatory trends related to Chinese cosmetics in 2020.
The 77thexecutive meeting of the State Council passed the new regulation on January 3,2020.The new regulation has made major adjustments to the regulatory methods of new cosmetic raw materials,cosmetic classification,toothpaste,and soap.For example:implement classified supervision of new raw materials according to the risk level;adjust the classification of cosmetics into special cosmetics and ordinary cosmetics according to the degree of risk;stipulate that the efficacy claims of cosmetics should have sufficient scientific basis and the qualification requirements of cosmetic safety assessors;propose the cosmetics registrant andnotification system for the first time;increase penalties;clarify that the main body responsible for online cosmetics sales and ordinary soaps are not cosmetics,and toothpaste refers to the management of ordinary cosmetics.The new regulation takes risk management as the core,further improve the regulatory measures,and has a positive and significant impact on regulating the development of the entire cosmetics industry.
In combination with the new regulation,the author envisioned the new era cosmetics regulatory system under the new regulations established by the State Drug Administration,as shown in Figure 1.[2-4]
Figure 1.Cosmetics regulatory system in the new era
In the picture,the regulatory documents under the “Measures for the Administration of Cosmetics Registration and Notification” include the “Regulations on Cosmetics Registration and Notification Data”,“Cosmetic classification rules and classification catalog”,“Guiding Principles for Quantitative Classification of General Cosmetics”,and “Technical Guidelines for Safety Risk Assessment of Cosmetics” ,“Guiding Specifications for the Evaluation of Cosmetic Efficacy Claims”,“List of Raw Materials Used in Cosmetics”,etc.;Regulations and documents under the “Methods for the Supervision and Administration of Cosmetics Production and Operation” include “Cosmetics Production Quality Management Regulations”,“Cosmetics Sampling Inspection Management Specifications”,“Cosmetic Risk Monitoring Work Regulations”,“Management Measures for Adverse Reaction Monitoring of Cosmetics”,“Administrative Measures for Supplementary Inspection Methods of Cosmetics”;regulatory documents under “Measures for the Supervision and Administration of Toothpaste”include “Toothpaste Registration and Notification Information Requirements” and “Toothpaste Classification Rules and Classification Catalogue”,“Toothpaste Used Raw Materials inventory”,“Toothpaste Supervision and Management Technical Guide”.
The “Measures for the Administration of Cosmetics Registration and Notification” was reviewed and approved at the 14th executive meeting in 2020 of the State Administration for Market Regulation on December 31,2020.It is hereby promulgated and shall come into force on May 1,2021.So far,the first departmental regulation specifically for the management of cosmetics registration and notification has been promulgated for the first time.
The Measures clarify the implementation of responsibilities and work requirements for supervision and management afternotification,reasonably set legal responsibilities,and increase penalties for violations of laws and regulations onnotification products.At the same time,it encourages innovation and clarifies that the cosmetics registrant and notifier can use the new raw material to protect the enthusiasm of new raw material research and development enterprises after the new raw material registrant and notifier agree.
On November 5,2020,the Cosmetics Supervision Department of the State Drug Administration issued the “Regulations on Cosmetics Registration andnotification Documents”(draft for comments).And the final version was issued on Mar 4,2021.
This regulation goes hand in hand with the“Regulations for the Registration and Recording of New Cosmetic Ingredients”.It is a detailed rule of the “Measures for the Administration of Cosmetics Registration and Notification”.It pointed that:product formula,product implementation standards,product label sample draft,product inspection report,product safety assessment data and other data should be provided when register or notify the product.If the registrant or notifier has independent production or entrusts production to an overseas production enterprise,it shall submit the production enterprise information form and the resume of the person in charge of quality and safety.The resume of the person in charge of quality and safety shall include the work experience and other content of the person in charge of quality and safety that proves that he meets the relevant requirements.
On November 5,2020,the Cosmetics Supervision Department of the National Medical Products Administration issued the “Regulations for the Registration andnotification of New Cosmetic Materials”(Draft for Solicitation of Comments).The final version was released on March 4,2021.
This regulation applies to the registration ornotification of natural or artificial raw materials used in cosmetics for the first time in the People’s Republic of China.It clears the requirements for text and translation,signatures,data formats,forms,reports,etc.;stipulates the registrant of new cosmetic raw materials.When applying for the registration or notification of new raw materials,the person shall submit the name,address and contact information of the registration or notification person and domestic responsible person;new raw material development report;new raw material preparation process,stability and quality control Standards and other research materials;new raw material safety assessment materials.
On July 29,2020,the Cosmetics Supervision Department of the State Food and Drug Administration issued a draft of “Technical Guidelines for Safety Risk Assessment of Cosmetics” for comments.The final version was released on April 9,2021.
The “Technical Guidelines for Safety Risk Assessment of Cosmetics” has been issued in China at the first time to guide and standardize the safety assessment of cosmetics.The guidelines point out that if the conclusions of the cosmetics safety assessment report are not sufficient to rule out the risk of the product to human health,toxicological test methods should be used for product safety assessment;the qualification requirements of safety assessors should be clarified.The risk assessment procedures stipulated in the guidelines are the same as those in the EU,indicating that domestic cosmetics supervision is gradually in line with international standards;a report template is listed.
The new regulation does specify that the drug regulatory department of the State Council shall formulate and publish cosmetic classification rules and classification catalogs.Therefore,on July 29,2020,the Cosmetics Supervision Department of the State Food and Drug Administration issued the “Rules and Catalogue of Classification of Cosmetics” for soliciting comments.The final version was released on April 9,2021.
The catalog is an important basis for judging whether a certain effect is a new effect.The line classification method is used to classify the cosmetics according to the effect claim,the part of action,the product formulation,and the user population,while considering the use method;the use of hierarchical code,code There are five levels,followed by efficacy claim A,action site B,product formulation C,user group D,and use method(washing type and resident type).The first to fifth layer codes are grouped together in order,and the layers are distinguished by “-”.Each layer uses 2 digits or letters to represent the code.When it comes to multiple efficacy claims,sites of action,product formulations,or users,they can be arranged in ascending order according to the established coding sequence.If the product is a combination package,it can be classified and coded as a product.
There are 28 categories of cosmetics claims in the catalog,including anti-wrinkle,firming,repair,soothing,acne(including blackheads),oil control,exfoliation,anti-hair loss,anti-breaking,antidandruff,hair color care,hair removal,deodorant,assist in shaving and shaving,etc.
The catalog divides the products into others,general population,infants(from birth to 3 years old),and children(before 3 to 12 years old)according to the user population.Some products suitable for pregnant women and lactating women shall be managed as special cosmetics;products suitable for infants and young children,such as claims of cleansing,moisturizing,moisturizing,sunscreen,soothing,and taming,shall be managed as special cosmetics;products suitable for children,such as Claims other than cleansing,makeup remover,moisturizing,moisturizing,beauty modification,hair styling,fragrance,hair care,sunscreen,repair,soothing,oil control,exfoliation,body conditioning,and anti-breakage,should be managed as special cosmetics.If the product does not limit the applicable population,the default product scope does not include people under 12 years old.
The catalog also clearly pointed out that products in other dosage forms are managed in accordance with special cosmetics.
In order to implement the new regulation,the National Institutes for Food and Drug Control issued the “Guiding Principles for the Evaluation of Cosmetic Efficacy Claims”(draft for comments)on September 1,2020.
This principle is based on extensive reference to relevant laws and regulations in Europe,the United States,Japan,and South Korea,as well as the evaluation methods and literatures of efficacy claims issued by industry/academic organizations,and fully integrates the current situation of the industry in my country to evaluate the content,scope,and responsibility of cosmetic efficacy claims.,general principles,method selection and institutional selection,etc.put forward basic requirements.This principle states that the main responsible for the evaluation of cosmetic efficacy claims is the registrant andnotification person of the cosmetics,who can undertake the evaluation of efficacy claims by themselves or by entrusting evaluation institutions with corresponding capabilities,and disclose the efficacy of cosmetics to the public on the website specified by the State Drug Administration.The summary of the claim basis,through social supervision,solves the problem of the authenticity of the efficacy claims that previously relied on administrative approval to solve the problem.At the same time,it is also clear that the evaluation methods can be selected from relevant domestic and foreign laws,standards,and norms,guidelines from authoritative organizations or technical institutions and industry associations,and published methods in professional academic journals,as well as validated laboratory self-developed methods.When there are multiple alternative evaluation methods for the same efficacy claim,the method in my country’s current laws and regulations,national standards or technical specifications should be selected first.
On November 5,2020,the Cosmetics Supervision Department of the National Medical Products Administration issued the “Guiding Specifications for the Evaluation of Cosmetic Efficacy Claims”(draft for comments).The final version was released on April 9.
The specification states that it can be directly recognized by the senses such as vision and smell(such as cleansing,makeup removal,beauty modification,fragrance,body conditioning,hair dyeing,perming,hair color care,depilation,deodorization,auxiliary shaving,etc.),or through simple Physical covering,adhesion,friction,etc.have effects(such as physical covering,freckle whitening,physical exfoliation,physical blackhead removal,etc.)and the label clearly identifies the efficacy claim that only has a physical effect,and the summary of the basis of the product efficacy claim can be exempted
The specification has specific requirements for the evaluation item requirements,evaluation methods,evaluation reports,etc.of efficacy claims.
On July 21,2020,the National Medical Products Administration issued a notice on the public comment on the “Measures for the Supervision and Administration of Cosmetics Production and Operation(Draft for comment)”.
The National Medical Products Administration has studied and drafted this method,which is of great significance to standardize the production and operation of cosmetics and strengthen the supervision and management of cosmetics after they are listed.The measures mainly implement the new regulations on cosmetics production and operation supervision from four aspects:detailed basic supervision system,strengthened supervision of key links,clarified supervision methods,and clarified legal responsibilities.
On September 27,2020,the Comprehensive Department of the National Medical Products Administration issued the “Cosmetics Production Quality Management Standards(Draft for comments)”.The practice includes nine parts and two appendices,including general rules,institutions and personnel,quality management,quality control,plant facilities and equipment,materials and products,production management,product sales management,and supplementary regulations.
The practice highlights the main responsibility of enterprises and emphasizes the principle of good faith;encourages enterprise innovation;stipulates that non-cosmetic products that adversely affect the quality of cosmetics should not be produced in cosmetics production workshops;it covers all the requirements of ISO 22716,and aims to guide domestic cosmetics manufacturers and international companies.Integrate,improve product quality,safety and internal quality,and promote the development of cosmetics international trade.
On September 27,2020,the Comprehensive Department of the State Drug Administration issued the “Management measures for adverse reaction monitoring of cosmetics(Draft for comments)”.
T he Measu res cla r if y t he reg ulator y responsibilities of different agencies.The National Medical Products Administration is responsible for the monitoring and management of cosmetic adverse reactions nationwide,and the department responsible for drug supervision and management of local people’s governments at or above the county level is responsible for the monitoring and management of cosmetic adverse reactions in their administrative regions;local authorities are responsible for the monitoring and management of cosmetic adverse reactions in their respective administrative regions.The drug supervision and administration department shall establish and improve the cosmetic adverse reaction monitoring institution,responsible for the technical work of the cosmetic adverse reaction monitoring within its administrative area.At the same time,clarify the social co-governance system mentioned in the new regulations,that is,the state encourages other units and individuals to report adverse reactions that may be related to the use of cosmetics to the cosmetics adverse reaction monitoring agency or the department responsible for drug supervision and management,and give full play to the role of social supervision.Promote cosmetic safety and social co-governance.The State Drug Administration is responsible for establishing the national cosmetics adverse reaction monitoring information system,strengthening the construction of the cosmetics adverse reaction and monitoring information network and database.
On September 27,2020,the Comprehensive Department of the National Medical Products Administration issued the “Management standards for sampling inspection of cosmetics(Draft for solicitation of comments)”.
The specification states that the State Drug Administration is responsible for organizing and carrying out national sampling inspections;the provincial drug supervision and administration department is responsible for organizing and implementing national sampling inspections within its administrative area,and is responsible for organizing provincial sampling inspections within its administrative area;The departments responsible for drug supervision and administration of the people’s governments at the city and county levels shall implement sampling inspections at the national and provincial levels in accordance with the deployment of the higher-level departments.For cosmetics that may have quality and safety risks found in complaints,supervision and inspection,adverse reaction monitoring,and risk monitoring,the department responsible for drug supervision and management at or above the county level may conduct special sampling inspections.
In order to implement the “Regulations on Supervision and Administration of Cosmetics,”Comprehensive Department of the National Medical Products Administration organized and drafted the“Administrative measures for supplementary inspection methods for cosmetics(Draft for comment).”
The Measures point out that the State Drug Administration shall organize the establishment of a cosmetic supplementary inspection method review committee,which is mainly responsible for making recommendations for the review of cosmetic supplementary inspection methods and method drafts.The Review Committee has an expert group and a secretariat.
The expert group is composed of personnel from the drug supervision and administration department,cosmetics inspection agency and other professional and technical institutions related to cosmetics,and is mainly responsible for the substantive technical review of the application of cosmetic supplementary inspection method and the draft method.
The secretariat is located in the China Institute for Food and Drug Control.It is mainly responsible for the formal review of the application of cosmetic supplementary inspection methods and method drafts,organizes expert group meetings for review and letter review,and submits the draft method,and is responsible for the establishment and approval of cosmetic supplementary inspection methods.Consultation work related to drafting,verification,review,and submission.
On November 13,2020,the State Drug Administration drafted the “Measures for the supervision and administration of toothpaste(Draft for solicitation of comments)”.
Toothpaste is managed in accordance with the new regulations on ordinary cosmetics,and it is determined that the regulatory functions of toothpaste before and after the market are adjusted to the State Drug Administration.Therefore,in order to implement the relevant provisions of the new regulations on toothpaste supervision,it is necessary to comprehensively consider the commonalities and specialties of toothpaste and cosmetics supervision.At the same time,in combination with the development and supervision of the toothpaste industry,a toothpaste supervision regulation is formulated to regulate the production of toothpaste.Production and operation,notification,and post-listing supervision and management.
Cosmetic labeling is closely related to the safety of cosmetic use and is the most direct way for consumers to obtain basic product information and safe use.Therefore,it is necessary to implement strict management.Therefore,on September 21,2020,the Cosmetics Supervision Department of the State Drug Administration issued the “Administrative measures for cosmetic labels”(Draft for comments).
The measures standardize and unify existing relevant regulations and documents,elaborate the purpose and scope of application of the legislation,define cosmetic labels,and specify the principle requirements of cosmetic label management and the main responsibilities of cosmetic registrants andnotification parties for cosmetic labels;It also stipulates the general labeling requirements and the labeling requirements of imported products;it also makes specific requirements for the content that should be marked on the cosmetics label and the labeling of various contents.At the same time,the Measures put forward some innovative regulatory measures,clarified the scope and requirements for the use of electronic labels,and also put forward corresponding requirements for the management of innovative terms and efficacy claims,and clarified that imported products should be labeled in Chinese,express and imply medical effects.Disguised illegal claims and management of prohibited words and other related matters.
The drafts of supporting documents for the new regulation have been released one by one.This has had a great impact on the cosmetics industry,but it is also an opportunity for industry reform and development.This also shows that cosmetics supervision is becoming more perfect and stricter.
On December 2,2020,the National Medical Products Administration issued theLetter on Soliciting Opinions on the Proposed Approval of lauroyl arginine ethyl ester HCl and other 4 Raw Materials as Raw Materials for Cosmetics.Then,a notice[2]was issued on December 28,2020.After review by the National Medical Products Administration Expert Committee on Cosmetics Technology Review and the Cosmetic Standards Expert Committee,it approved the use of lauroyl arginine ethyl ester HCl as a cosmetic preservative and was included in Permitted preservatives for cosmetics in Chapter 3 of “Safety and Technical Standards for Cosmetics”(2015)(Table 4);approved methoxy PEG-23 methacrylate/glycerol diisostearate methacrylate copolymer,etc.raw materials used as cosmetic raw materials.The use of the aforementioned raw materials to produce cosmetics shall comply with relevant laws,regulations and standards.
In order to meet the needs of the development of the cosmetics industry and safety supervision,the National Institutes for Food and Drug Control issued a notice on soliciting revisions to the “Safety and Technical Standards for Cosmetics“(2015)on March 6,2020,and then issued the “Notice on Soliciting Opinions[3]on the Catalogue of Banned Cosmetic Ingredients,etc.” on January 22,2021.The opinion contains 5 attachments,namely “Table 1 List of Prohibited Cosmetic Ingredients(Draft for Solicitation of Comments)”,“Table 2 List of Prohibited Plant(Animal)Raw Materials for Cosmetics(Draft for Solicitation of Comments)” and“Table 3 List of Prohibited Cosmetics” Before and After Comparison Table,“Table 4 List of Prohibited Plant(Animal)Raw Materials for Cosmetics Comparison Table Before and After Revision” and“Instructions for the Preparation and Revision of List of Prohibited Cosmetic Materials.
The “Prohibited ingredient list” is based on the content and style of the banned and restricted components of cosmetics in Chapter 2 of the “ Safety and Technical Standards for Cosmetics”(2015),combined with the evaluation results,recent international and domestic cosmetic safety regulatory requirements and changes,and refer to relevant specifications It’s written as a sexual document.The main contents are:17 new banned raw materials for cosmetics;revision of 13 banned raw materials for cosmetics;adjustment of text content in accordance with the requirements of cosmetic safety technical regulations;classification and consolidation of banned drug ingredients;revision of 27 banned plants(animals)raw material.
The use of cosmetic raw materials is closely related to the quality and safety of cosmetics.With the development of the cosmetics industry and the improvement of scientific understanding,according to the risk assessment results of some cosmetic raw materials in my country,we also refer to the EU,the United States and other developed countries or regions in the cosmetics industry in recent years.Some cosmetics evaluations and regulatory adjustments found that some raw materials urgently need to be adjusted for management and use requirements.In order to effectively ensure the safety of consumers,in accordance with the principle of strict management,the regulations on the management of prohibited raw materials in my country’s “Technical Specifications for Cosmetic Safety”(notification)need to be adjusted urgently.
On January 26,2021,the National Institutes for Food and Drug Control issued a notice on soliciting opinions on the list of used cosmetic raw materials.[4]The opinion lists a total of 8,980 kinds of raw materials,which is 197 more than the 8,783 kinds of the used catalog in the notification.In addition,the information on the highest historical usage of raw materials has been added to the catalog,and restricted ingredients,preservatives,sunscreens,colorants,and hair dyes that are not included in the “Cosmetics Safety Technical Specification” are deemed to have been used.Raw materials are added to the used list;the categories of raw materials in the list,such as:orchid extracts,algae extracts.According to the specific use of the raw materials in the cosmetics administrative license management system,the specific names of the used raw materials are added to the used list.Use catalogue;if a raw material serial number in the catalogue corresponds to two names,according to “International Cosmetic Raw Material Dictionary and Manual”,“Chinese Pharmacopoeia”,“Chinese Flora”,one of the standard names is retained,and the other is adjusted to “Zeng Name”.
This inventory is an objective collection of the raw materials used in cosmetics produced and sold in my country.A systematic evaluation of the safety of the raw materials listed in this catalog is not organized.When selecting the raw materials listed in this catalog,the cosmetics registrant and recorder shall comply with relevant national laws,regulations,standards,and specifications,and bear the responsibility for product quality and safety.This list is also an important basis for confirming whether a cosmetic ingredient is a new ingredient list.
On November 20,2020,the National Institutes for Food and Drug Control issued a notice on publicly soliciting opinions on the “Methods for the Determination of Boric Acid and Borate in Cosmetics”.[5]The opinions contained 7 attachments,including “Methods for the detection of boric acid and borate in cosmetics(Draft for comments)”,“Methods for the detection of 32 hair dyes such as p-phenylenediamine in cosmetics(Draft for comments)”,“2-amino-4-hydroxyethyl in cosmetics”Methods for the detection of 15 hair dyes including anisole sulfate(Draft for comments),“Methods for the detection of retinoic acid and its derivatives in cosmetics(Draft for comments)”,and “in vitro mammalian cell micronucleus test(Draft for comments)”,“Evaluation method of freckle-removing and whitening effect of anti-freckle and whitening cosmetics(draft for comments)”,“Evaluation method of anti-dropping efficacy of anti-hair loss cosmetics(Draft for comments)”.
From the aspects of new raw material approval,banned raw material catalog adjustment,used name catalog update,and some raw material testing methods,this undoubtedly reflects that China’s cosmetic raw material supervision has entered a new stage,and the raw material risk monitoring system is gradually being constructed,and it is also for the follow-up.The new cosmetics regulatory system provides strong support.
The National Press and Publication Administration issued “CY/T 226.1-2020 Cosmetic Packaging Printing Quality Control Requirements and Inspection Methods Part 1:Paper Packaging” on November 16,2020,which will be implemented on February 1,2021.This standard applies to the quality control of the production of folding cartons,fixed cartons,and paper inner trays for cosmetics.It specifies the terms and terms involved in the quality control of cosmetic cartons,packaging and printing products printed on paper materials or paper composites.Definitions,technical requirements and inspection methods.
In addition,the National Press and Publication Administration also issued “CY/T 226.2-2020 Cosmetic Packaging Printing Quality Control Requirements and Inspection Methods Part 2:Tube Packaging” on the same day.This standard is applicable to the quality control requirements and inspection methods of the cosmetic packaging hoses made of resin materials,resin and aluminum foil composite materials in the printing process,and specifies the plastic cosmetic hose packaging involved in the printing process Terms and definitions,technical requirements and inspection methods.
The above two standards have made specific provisions on the quality control requirements and inspection methods of different types of cosmetic packaging.
The Shanghai Medical Products Administration has reviewed and approved the “Measures of Drugs,medical devices and cosmetics safety responsibilities interviews” at the 15th administrative meeting in 2020,which have been implemented on December 1,2020.The promulgation of the Measures,based on the actual situation in Shanghai,can further strengthen the safety supervision of drugs,medical devices,and cosmetics,implement the main responsibility of enterprises,control and prevent illegal acts and safety incidents in drugs,medical devices,and cosmetics,and enhance the effectiveness of supervision..
On November 19,2020,the Shanghai Medical Products Administration issued the “Guidelines for the notification of First-Class Medical Devices in Shanghai”,which clarified that various models such as “mask type” and “moisturizing type” do not meet the notification requirements.The difference between“machinery number” and “cosmetic number” is clearly defined,and the “machinery number” is not stopped across the board.The work guidelines of the Shanghai Medical Products Administration not only point out the direction for the chaotic machine names,but they are indeed a manifestation of “strictly managing violations and tolerating innovation.”
The author believes that Shanghai is very likely to be a pilot project for the Notional Medical Products Administration to rectify the ‘Machine Brand’.The“Guide” clarifies that various models such as “mask type” and “moisturizing type” do not meet the notification requirements,and for the first type of dressing type,enterprises are required to submit all added ingredients and content information,as well as the role of ingredients,and require liquids The relevant ingredients added in the formulations of dressings and ointments cannot be absorbed by the body.
On November 12,2020,the Guangdong Medical Products Administration organized and revised the“ Regulations on the management of the Blacklist of Drugs,Medical Devices and Cosmetics” to further strengthen the safety supervision of cosmetics and increase punishment for violations of laws and regulations Strengthening,implementing the main responsibilities of producers and operators,and advancing the establishment of a credit system are of great guiding significance.
The regulations state that:the Provincial Medical Products Administration is responsible for the management of the “two products and one tool”and “blacklist” in the province;the city and county drug regulatory authorities(hereinafter referred to as the “drug regulatory authorities”)are responsible for the administrative area.“Two products and one tool” “blacklist” information management work;drug regulatory agencies at or above the county level shall,in accordance with the requirements of these regulations,include information on administrative punishments for serious illegal and untrustworthy acts that are severe in nature,serious in circumstances,and severe in social harm into the “black list”.The list" is announced to the public through government websites and other means.
The information published on the “blacklist”should include:The name of the illegal producer and business operator,the unified social credit code,the illegal facts,the basis for the punishment(judgment),the result of the punishment(judgment),the time limit for publication,etc.;The names and ID numbers of the legal representative,the main person in charge,the directly responsible person in charge,and other responsible persons,the illegal facts,the basis for the punishment(judgment),the result of the punishment(judgment),and the time limit for publication wait;The time limit for the publication of the “blacklist” should be consistent with the time limit for which behavior restriction measures are taken in accordance with the law.Where laws and administrative regulations do not specify the time limit for behavior restriction measures,the publication time limit shall be 3 years,and the publication time limit shall be calculated from the date of publication.Drug regulatory authorities at all levels will record the“two products and one tool” producers and operators included in the “blacklist” into the regulatory credit file and implement key supervision.
After undergoing major changes in 2018,the cosmetics industry has also undergone a major reshuffle in 2020.The first is the introduction of new regulations,and the corresponding supporting documents for soliciting opinions;the second is the release of the list of used cosmetics raw materials and the revised opinion drafts of the “Safety and Technical Standards for Cosmetics”( 2015),approval 4 new raw materials;in addition,except for policy changes at the national level,local regulations based on local conditions have also been issued.Although they are not implemented nationwide,they also have important reference and guiding significance.The construction of a new regulatory system for cosmetics is more conducive to the healthy development of the cosmetics industry,but the requirements for enterprises are also higher and higher,and the cost of illegality has also increased.Therefore,it is recommended that companies use third-party training,official training and other opportunities to learn more about the requirements of the new regulations,and to be familiar with the requirements of supporting documents to avoid being notified that the product is not qualified after the product is on the market,affecting the corporate reputation and causing unnecessary economic losses.
China Detergent & Cosmetics2021年3期